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U.S. Department of Health and Human Services

Class 2 Device Recall 10 cc NonSterile Syringe

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 Class 2 Device Recall 10 cc NonSterile Syringesee related information
Date Initiated by FirmJune 27, 2005
Date PostedAugust 03, 2005
Recall Status1 Terminated 3 on April 19, 2007
Recall NumberZ-1076-05
Recall Event ID 32510
510(K)NumberK911732 
Product Classification System, X-Ray, Angiographic - Product Code IZI
ProductProduct consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows: Product Label ''***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir SINGLE USE ONLY***REF/REORDER NO. 093205***This device is designed for the administration and removal of fluids***Quantity: 25ea***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended***1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***'' Carton Label ''***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir SINGLE USE ONLY***REF/REORDER NO. 093205***This device is designed for the administration and removal of fluids***Quantity: 250ea***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended***1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***''
Code Information Reorder #: 00-093207 - Lot #: 99442547     
Recalling Firm/
Manufacturer		 Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
Manufacturer Reason
for Recall		The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip.
FDA Determined
Cause 2		Other
ActionThe firm plans to distribute recall letters to all customers indicated on the customer list. TELEPHONE 6/27/2005. All products will be returned to Argon and disposed.
Quantity in Commerce1008 syringes
DistributionTN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IZI
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